BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOLOX CERAMIC HEAD

    MDR report key: 1012302 · Received February 4, 2008

    Report

    Report Number
    3002806535-2008-00002
    Event Type
    Other
    Date Received
    February 4, 2008
    Date of Event
    December 11, 2007
    Report Date
    February 7, 2008
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    K042091
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE USER FACILITY IS OUTSIDE OF THE US. NO MEDWATCH REPORT WAS RECEIVED. NO USER FACILITY INFO IS AVAILABLE. EVAL IN PROCESS, BUT NOT YET COMPLETE. UPON COMPLETION OF EVAL, A FOLLOW UP REPORT WILL BE FORWARDED TO THE FDA. THIS REPORT FILED ON MARCH 4, 2008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT UNDERWENT RIGHT PRIMARY HIP ARTHROPLASTY IN 2004. SUBSEQUENTLY, PT REPORTED PROBLEMS WITH HIS RIGHT HIP. IN 2007, PT REPORTED THAT STRANGE SOUNDS HAD BEEN COMING FROM HIS HIP FOR THE LAST 3 WEEKS. REVISION PROCEDURE WAS PERFORMED FOUR DAYS LATER, WHERE CERAMIC HEAD WAS FOUND FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOLOX CERAMIC HEAD LZO BIOMET UK LTD. NA 766066

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| L